Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Remodulin |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Medtronic, Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432-5604 |
PMA Number | P140032 |
Supplement Number | S001 |
Date Received | 01/22/2018 |
Decision Date | 07/27/2018 |
Withdrawal Date
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08/18/2021 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Post-Approval Study protocol as a condition of approval for P140032 of the Medtronic Implantable System for Remodulin (ISR) for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P140032. |
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